Background:
A group of Nigerian children and their guardians alleged that Pfizer experimented on 200 children suffering from meningitis without their consent or knowledge. At the time of the 1996 meningitis epidemic in northern Nigeria, Pfizer was attempting to obtain Food and Drug Administration (FDA) approval for a new antibiotic Trovafloxacin Mesylate (Trovan). The complainants further alleged that Pfizer purposefully under-dosed the children treated with the well-established and FDA-approved drug Ceftriaxone in order to skew the trial results in favour of Trovan. 11 children died as a result of the trial and many others were left blind, paralysed or brain-damaged.

The complainants filed a claim under the Alien Tort Statute (ATS) grounded in the prohibitions of the Nuremberg Code, the World Medical Association's Declaration of Helsinki, the guidelines of the Council for International Organisations of Medical Services and the International Covenant on Civil and Political Rights which categorically forbid medical experimentation without consent.

Issue and resolution:
Prohibition on medical experimentation on non-consenting human subjects. Although the US has not ratified or adopted the above international instruments, the ATS provides that District Courts have jurisdiction in civil actions committed in contravention of the law of nations, or customary international law. The Second Circuit Court of Appeal held that the restriction on medical experimentation without consent is a norm of international law and is capable of being enforced under the ATS. The case was subsequently referred back to the District Court for further proceedings.

Court reasoning:
The Court held that the three-part test to determine whether the restriction was an obligation under customary international law was satisfied. The test required the restriction to be (1) universal in nature; (2) specific and definable; and (3) of mutual concern. The Court gave the following reason for each strand of the test:

(1) The legal principles of the Nuremberg Code and the ICCPR are examples of the normality and universality of this restriction;

(2) The allegations stated that Pfizer carried out these experiments knowingly and purposefully which went beyond a simple isolated case of failing to obtain consent, and would therefore be clearly covered by the restriction on experimentation on non-consenting human beings; and

(3) The case was of mutual concern to both the US and Nigeria as such conduct could foster distrust, reduce co-operation between nations and generate substantial anti-American feeling in the region.

Dissenting Opinion:
Circuit Judge Wesley dissented for the following reasons: (1) customary international law only applies to state actors and not to private actors such as Pfizer; (2) the restriction should not be regarded as a customary norm simply because other States have prohibited this behaviour; (3) the international instruments listed above were put forward by private organisations who were not in a position to create laws; and (4) some of the instruments came into effect after the incident happened without reference to any retrospective effect.

Impact:
In July 2009, Pfizer petitioned the US Supreme Court to appeal this ruling. In November, the Supreme Court asked the US Solicitor General to file a brief, which he did in May 2010, denying Pfizer's petition. On 23 February 2011, the parties announced that they had reached a confidential settlement in the lawsuit.

Following various proceedings in Nigeria, Pfizer and the Kano state government came to an out-of-court settlement worth $75 million in August 2009. A new lawsuit was filed by the victims in November 2013 in the Federal High Court in Kano who complained that, by restricting the criteria for compensation, Pfizer had breached the terms of the 2009 agreement. In November 2014, Pfizer paid out full and final compensation to the 14 victims who passed the DNA tests in accordance with the terms of the 2009 settlement.

Countries

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